Edwards Lifesciences announced positive one-year results from the TRISCEND II trial, showcasing the superiority of its EVOQUE transcatheter tricuspid valve replacement (TTVR) system over optimal medical therapy for severe tricuspid regurgitation. The study, involving 400 patients, revealed a 95.4% successful implantation rate and a 95.3% rate of near-complete tricuspid regurgitation elimination at one year in treated patients, compared to only 2.3% in the control group.
The data, presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting, highlighted significant improvements in symptoms, function, and quality of life. These outcomes mark a significant advancement in treating tricuspid regurgitation, a condition affecting millions worldwide.
Significant Clinical Improvements
The TRISCEND II trial, a randomized controlled study, compared the EVOQUE system plus optimal medical therapy to optimal medical therapy alone in patients with severe tricuspid regurgitation (TR). The primary endpoint focused on the one-year outcomes. The results, simultaneously published in The New England Journal of Medicine and the Journal of the American College of Cardiology, demonstrated the EVOQUE system's significant impact.
Susheel Kodali, MD, Principal Investigator of the TRISCEND II Study, noted the importance of having the EVOQUE system as a treatment option for severely ill patients with limited alternatives. He also stated that, “The one-year outcomes from the TRISCEND II trial demonstrate the benefits of this therapy in these patients and the favorable trends in all-cause mortality and heart failure hospitalization are encouraging to see. We are pleased to see TTVR reach this stage after nearly a decade of development.”
Quality of Life Benefits
Beyond clinical metrics, the TRISCEND II trial also assessed the quality of life (QoL) improvements in patients receiving the EVOQUE system. Suzanne Arnold, MD, MHA, stated that, “Patients receiving TTVR with the EVOQUE system were twice as likely to be alive with a good quality-of-life at one year, compared with the control group.”
EVOQUE System Details and Availability
The EVOQUE system is now approved for use in both Europe and the US, making it the first and only approved TTVR system globally. It is available in four valve sizes (44mm, 48mm, 52mm, and 56mm), with the 56mm valve recently approved in the US, allowing treatment for a broader range of patients.
Edwards Lifesciences' Commitment
Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies, emphasized the company's dedication to innovation and building a comprehensive portfolio of transcatheter repair and replacement technologies. He stated, “We are building a portfolio of transcatheter repair and replacement technologies for both the mitral and tricuspid valves, and we are dedicated to supporting those therapies with world-class evidence like what is being generated through the TRISCEND II trial.”
